Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca (AZN) and Daiichi Sankyo reported initial results from a TROPION-PanTumor03 sub-study showing DATROWAY (datopotamab deruxtecan) plus rilvegostomig produced a confirmed objective response rate (ORR) of 68.2% (95% CI: 45.1–86.1) and disease control rate (DCR) of 95.5% (80% CI: 83.4–99.5) in cisplatin-ineligible first-line metastatic urothelial cancer (n=22).

In the second-line, previously platinum-treated/immunotherapy-naïve cohort (n=18), ORR was 38.9% (95% CI: 17.3–64.3) and median progression-free survival (PFS) was 12.5 months (95% CI: 4.2–NR). Median duration of response was not reached in either cohort. Safety was consistent with known profiles: grade ≥3 treatment-related adverse events occurred in 18.2% (first-line) and 38.9% (second-line); adjudicated ILD events were 1 (4.5%) and 2 (11.1%), respectively.

AstraZeneca (NYSE:AZN) reported that the POTOMAC Phase III trial met its primary endpoint: adding one year of IMFINZI (durvalumab) to BCG induction and maintenance reduced the risk of high-risk non-muscle-invasive bladder cancer recurrence or death by 32% (DFS HR 0.68; 95% CI 0.50-0.93; P=0.0154) with median follow-up of 60.7 months. Estimated 24-month DFS rates were 86.5% (IMFINZI+BCG) vs 81.6% (BCG). OS was not formally powered; descriptive OS HR was 0.80 (95% CI 0.53-1.20) at 65.6 months. Grade 3‑4 adverse events occurred in 34% (IMFINZI arm) vs 17% (BCG). Results presented at ESMO 2025 and published in The Lancet.

AstraZeneca (NYSE:AZN) announced results from the MATTERHORN Phase III trial showing a perioperative IMFINZI (durvalumab) plus FLOT regimen reduced the risk of death by 22% versus chemotherapy alone (HR 0.78; 95% CI 0.63-0.96; P=0.021) in resectable Stage II–IVA gastric and gastroesophageal junction cancer. Median OS was not reached in either arm at data cut-off Sept 1, 2025. Estimated 3-year OS was 69% with IMFINZI-FLOT versus 62% with FLOT alone. Prior EFS analysis showed a 29% reduction in risk (HR 0.71; P<0.001).

AstraZeneca (NYSE:AZN) unveiled an expanded manufacturing facility in Coppell, Texas on October 15, 2025, backed by a $445 million investment to double Lokelma production for the US and global markets.

The expansion adds a 9,000 sq ft building, two novel manufacturing lines, upgraded labs, warehousing, utilities and administrative space. Coppell is the sole global Lokelma manufacturing site serving >50 countries and employs >250 people.

This project follows a recent groundbreaking in Virginia and is part of AstraZeneca’s announced $50 billion US R&D and manufacturing commitment over five years; the company reported creating approximately $20 billion of value to the US economy in 2025.

AstraZeneca (AZN) will present new clinical data at ESMO Congress, Oct 17–21, 2025, featuring first readouts from four major pivotal trials and more than 95 abstracts across approved and pipeline medicines.

Key highlights include Presidential Symposium presentations of DESTINY-Breast11 and DESTINY-Breast05 on ENHERTU in HER2-positive early breast cancer, primary results from TROPION-Breast02 on DATROWAY in metastatic TNBC, and POTOMAC and MATTERHORN results for IMFINZI in early bladder and gastric cancers. The program also features 26 oral presentations and data on multiple ADCs, IO bispecifics and combination regimens.

AstraZeneca (AZN) will increase investment in a new Virginia manufacturing facility to $4.5 billion, a $500m boost to expand capability to produce a broader range of medicines including weight‑management small molecules and antibody drug conjugate (ADC) cancer therapies.

The Rivanna Futures site in Albemarle County is expected to create approximately 3,600 jobs (about 600 ongoing skilled roles and 3,000 construction roles). Work starts immediately and the facility is expected to be operational in 4–5 years. The project is part of a $50 billion U.S. R&D and manufacturing commitment and will deploy AI, automation, and data analytics.

Turbine announced a collaboration with AstraZeneca (AZN) on October 9, 2025 to apply Turbine's virtual disease models to antibody-drug conjugate (ADC) discovery.

The partnership will use a lab-in-the-loop workflow where Turbine recommends a strategic subset of cell lines for wet-lab testing, then predicts outcomes across thousands of in silico models using AstraZeneca's ADC datasets, covering single-agent and combination studies. Goals include reducing large-scale cell line screening, improving speed and efficiency of ADC discovery, and delivering mechanistic insights by modeling cell survival and gene-expression changes to inform ADC positioning and clinical translatability.

AstraZeneca (NYSE:AZN) announced that baxdrostat met the primary endpoint in the Phase III Bax24 trial, showing a statistically significant and clinically meaningful reduction in ambulatory 24-hour average systolic blood pressure versus placebo at Week 12 in patients with resistant hypertension.

The randomized, double-blind study randomized 218 participants 1:1 to baxdrostat 2 mg or placebo for a 12-week double-blind period. Efficacy was observed across the full 24-hour period, including the high-risk early morning window. Baxdrostat was generally well tolerated with a safety profile consistent with prior BaxHTN results. Data will be shared with regulators and presented at AHA Scientific Sessions November 2025.

AstraZeneca (NYSE:AZN) and Daiichi Sankyo announced positive Phase III TROPION-Breast02 results for DATROWAY (datopotamab deruxtecan-dlnk) on October 6, 2025.

DATROWAY showed a statistically significant, clinically meaningful improvement in overall survival (OS) and a highly statistically significant improvement in progression-free survival (PFS) versus investigator's choice chemotherapy as 1st-line treatment for metastatic triple-negative breast cancer (TNBC) patients for whom immunotherapy was not an option. Approximately 70% of metastatic TNBC patients are not candidates for immunotherapy.

The safety profile was consistent with prior trials; common adverse reactions included stomatitis (63%), ocular reactions (36%), and ILD/pneumonitis observed in the pooled breast-cancer population at 3.6% (one fatal case, 0.2%). Data will be presented at a medical meeting and shared with regulators.